NCT04324359已完成2 期
A Multicenter, Randomized, Double-Masked Study To Compare The Ocular Safety, Tolerability, And Efficacy Of A Topical 0.2% Ophthalmic Corticosteroid Solution (SURF-201) To Vehicle In Cataract Surgery Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 10
- 主要终点
- Anterior Chamber Cell (ACC) Grade: Number of Participants Achieving an ACC Grade of 0
研究概览
简要总结
SURF-201 is being studied for the treatment of eye inflammation and pain in people who are undergoing cataract surgery. SURF-201 is an investigational drug (which means the study drug is currently being tested) in the form of a sterile eye drop.
The purpose of this research study is to see how well SURF-201 works and what side effects there are, and to compare it with Vehicle (placebo). This study will involve about 80 study participants at several different research sites in the United States.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult subjects age 18 years or older scheduled for uncomplicated unilateral cataract surgery with posterior chamber intraocular lens (IOL) implantation.
- •Subjects must be able to understand and sign the Informed Consent Form (ICF).
- •Female subjects of childbearing potential must agree to and submit a negative urine pregnancy test before any study-specific procedures are performed. The subjects must be using and continue to use a suitable method of contraception for the duration of the study: spermicide with barrier, oral contraceptive, transdermal contraceptive, injectable or implantable contraceptive, intrauterine device (IUD), abstinence or surgical sterilization of a partner. If a subject is not of childbearing potential (e.g., has been postmenopausal for at least 12 months or is premenarchal, or has undergone a hysterectomy, bilateral oophorectomy or a bilateral tubal ligation), a urine pregnancy test and use of a suitable method of contraception for the duration of the study will not be required.
- •Subjects must have a best-corrected visual acuity (BCVA) of at least +1.0 log of the minimum angle of resolution (logMAR) (Snellen equivalent of 20/200) in the non-study eye (fellow eye).
- •Subjects must have an intraocular pressure (IOP) of >8 mmHg and ≤22 mmHg in the study eye (surgery eye).
- •Subject must agree to maintain their current dosing regimen throughout the study period (from Screening through Day 32) if they are currently using topical cyclosporin-A or Xiidra (lifitegrast 5%).
- •Subjects must be willing and able to attend all study visits and follow all instructions.
- •Subjects must be able to self-instill the study drug (if unable, a caregiver must be available to instill all doses of the study drug).
- •Subjects must agree to avoid any medications which are disallowed (as defined by the protocol).
排除标准
- •Subject has any intraocular inflammation (cells and flare in the anterior chamber) or ocular pain (pain score of >0) in either eye prior to surgery.
- •Subject has any extraocular inflammation in the study eye prior to surgery (blepharitis is allowed if only scurf is present without any concurrent conjunctivitis or lid erythema/edema) or ongoing uveitis.
- •Subject has a history of diabetic retinopathy and/or previous vitrectomy in the study eye within the last 2 years prior to Screening which, in the investigator's opinion, is clinically significant and could impact the normal outcome of an uncomplicated cataract surgery.
- •Subject has a diagnosis of severe dry eye in the study eye.
- •Subject has any sign of iritis or scleritis in the study eye.
- •Subject has a history of glaucoma surgery in the study eye within the last 2 years prior to Screening.
- •Subject has a history of retinal surgery in the study eye within the last 2 years or plans to undergo retinal surgery in the study eye during the study period (from Screening through Day 32)
- •Subject has a history of Fuchs' dystrophy in the study eye.
- •Subject has guttata or chalazion in the study eye.
- •Subject has undergone radial keratotomy, photorefractive keratotomy, advanced surface ablation, corneal transplant, or LASIK in the study eye within the last 2 years prior to Screening.
- •Subject plans to undergo cataract surgery in the non-study (fellow) eye during the study period (from Screening through Day 32).
- •Subject plans to undergo additional ocular surgery (including femtosecond laser-assisted cataract surgery, minimally invasive glaucoma surgery, astigmatic keratotomy, limbal relaxing incision surgery, mechanical pupillary expanders, conjunctival incisions, and vitrectomy) in either eye during the study period (from Screening through Day 32).
- •Subject has a history of intraocular injections in the study eye within 6 months prior to Screening.
- •Subject has a history of herpes simplex infection in either eye.
- •Subject has active corneal, conjunctival or canalicular pathology (including ocular infection [bacterial, viral or fungal]) in the study eye. Specifically, active viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of the ocular structures (such as fungal keratitis).
- •Subject has thinning of the cornea or sclera.
- •Subject plans to undergo uncomplicated unilateral cataract surgery with the aid of anterior capsular staining products (e.g., Trypan blue) or with the aid of a femto (femtosecond) laser.
- •Subject has undergone anti-neoplastic therapy within the last 2 years prior to Screening or plans to undergo anti-neoplastic therapy during the study period.
- •Subject has a history of use of medications to treat benign prostatic hyperplasia that, in the opinion of the investigator, limits adequate dilation of the pupil to safely perform uncomplicated cataract removal and IOL implantation.
- •Subject has a history of liver disease within the last 5 years prior to Screening.
- •Subject has a history of previous ocular trauma in the study eye that places the study eye at risk of increased post-surgical complications or inflammation.
- •Subject has or had a known blood dyscrasia or bone marrow suppression.
- •Subject has an active or chronic/recurrent ocular or systemic disease that is not controlled and may have an impact on would healing (e.g., diabetes mellitus, systemic connective tissue disease, severe atopic disease).
- •Subject is suffering from alcohol and/or drug abuse.
- •Subject has a known hypersensitivity or poor tolerance to corticosteroids or any component of the study drug or any of the procedural medications such as anesthetic and/or fluorescein drops, dilating drops, etc.
- •Female subjects who are currently pregnant or nursing or are planning to become pregnant during the study or have a positive pregnancy test.
- •Subject has previously participated in this study protocol.
- •Subject used (within 30 days of initiation of study treatment) or is anticipating concurrent use of an investigational drug or device.
- •Subject has a condition or a situation which, in the investigator's opinion, might put the subject at increased risk, confound the study data or interfere significantly with the subject's study participation.
- •Subject would be wearing contact lens in either eye during the dosing period of Day -1 to Day
- •Subject is taking a medication that the investigator feels might interfere with the study parameters.
- •Subject tests positive for the Coronavirus Disease 2019 (COVID-19) virus prior to Visit 1 (Day -14 to Day -2).
研究组 & 干预措施
SURF-201
Experimental
0.2% topical preservative-free corticosteroid solution (0.2% betamethasone sodium phosphate)
干预措施: SURF-201 (Drug)
Vehicle
Placebo Comparator
Topical preservative-free vehicle (Placebo)
干预措施: Placebo (Drug)
结局指标
主要结局
Anterior Chamber Cell (ACC) Grade: Number of Participants Achieving an ACC Grade of 0
时间窗: Day 15
The Investigator used a slit lamp biomicroscope to assess ACCs in the study (surgery) eye. ACC counts were graded as follows: ACC Grade 0 = 0 cells were seen ACC Grade higher than 0 = 1 or more cells were seen
次要结局
- Post-surgical Ocular Pain Score: Number of Participants Achieving an Ocular Pain Score of 0(Day 32)
研究者
研究点 (10)
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